U.S. pharmaceutical company Moderna said Wednesday interim studies it has conducted indicated its COVID-19 vaccine is safe and effective for very young children, and the company is submitting a request for its approval to U.S. and international drug regulators.

In a release published on its website, Moderna said interim data from its Phase 2/3 Study showed “a robust neutralizing antibody response” from a 25 microgram two-dose series of its vaccine among children ages 6 months to just under 2 years of age, and children from 2 years to just under 6.

Based on these results, the company said it will submit a request for approval for the two-dose series for children 6 months to just under 6 years old to the U.S. Food and Drug Administration, the European Medicines Agency and other global regulators in the coming weeks.

If approved, it would be the first vaccination available in the United States for children under the age of 5. The Pfizer-BioNTech vaccine is currently available in smaller doses for children 5 to 12, and in full-size doses for those 12 and older.

An initial trial of the Pfizer vaccine for 2- to 4-year-olds showed a weaker immune response than in adults, forcing the trial to be extended to test a third dose. Results are expected in April.

Some information for this report was provided by The Associated Press, Reuters and Agence France-Presse.
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